FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KETOCHECKS
K Number: K033114
·
Decision Apr 26, 2004
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
23
Applicant Total
1
Review Days
209
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Basic Information
- Device Name
- KETOCHECKS
- K Number
- K033114
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1435
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neo Diagnostics, Inc.
- Date Received
- September 30, 2003
- Decision Date
- April 26, 2004
- Product Code
- JIN
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
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